Market Overview

AmpliPhi Biosciences Reports Third Quarter 2018 Financial Results and Business Highlights

Share:
  • The company intends to initiate one or more clinical trials in 2019
    following positive FDA feedback
  • Announced positive updated results from the company's expanded
    access program: 21 patients with serious or life-threatening
    infections were treated at 7 hospitals, with 84% treatment success at
    the end of therapy
  • Raised gross proceeds of $6.8 million through an underwritten
    public offering

AmpliPhi Biosciences Corporation (NYSE:APHB), a
clinical-stage biotechnology company focused on precisely targeted
bacteriophage therapeutics for antibiotic-resistant infections, today
announced financial results for the third quarter ended September 30,
2018. AmpliPhi Biosciences will not be conducting a conference call in
conjunction with this financial release.

"We made significant progress in the third quarter of 2018. We announced
an updated set of positive outcomes from our ongoing expanded access
program for seriously ill patients, who suffer from resistant bacterial
infections. Additionally, we received agreement from the FDA to proceed
to randomized clinical trials for our lead product candidates, AB-SA01
and AB-PA01," said Paul C. Grint, M.D., CEO of AmpliPhi Biosciences.
"AmpliPhi now intends to initiate one of the FDA agreed clinical trials
for AB-SA01 in 2019, the bacteremia trial, and also to seek non-dilutive
financing for our AB-PA01 program."

Recent Business Highlights

  • Announced in September 2018 that 84% of patients achieved treatment
    success at the end of therapy for the company's expanded access
    program. Twenty-one patients at 7 hospitals, with serious or
    life-threatening infections not responding to antibiotics, were
    treated with AB-SA01 or AB-PA01. Over 1,000 doses of AmpliPhi's
    bacteriophage product candidates have now been administered as part of
    the program since mid-2017. Treatment was generally well tolerated,
    with no treatment-related serious adverse events.
  • Received positive U.S. Food and Drug Administration (FDA) feedback for
    AB-SA01 in September 2018, following a Type B pre-IND meeting.
    AmpliPhi announced that the FDA is in general agreement with the
    design of two proposed randomized clinical trials of AB-SA01, for S.
    aureus
    bacteremia and prosthetic joint infections, and that no
    additional preclinical or clinical data are required to proceed with
    both trials. In addition, AmpliPhi continues to investigate if AB-SA01
    may be eligible for approval under the limited population pathway for
    antibacterial and antifungal drugs (LPAD) which is intended to
    facilitate development of therapeutics to treat serious or
    life-threatening infections in a limited population of patients with
    unmet need.
  • Received positive feedback from the FDA for AB-PA01 in September 2018.
    The company announced that the FDA is in general agreement with the
    design of two proposed randomized clinical trials of AB-PA01,
    hospital-acquired and ventilator-associated pneumonia (HAP/VAP) due to P.
    aeruginosa
    and for P. aeruginosa bacteremia, and no
    additional preclinical or clinical data are required to proceed.
    AmpliPhi intends to seek non-dilutive financing and explore other
    opportunities to conduct these clinical trials.
  • Presented clinical case data from the expanded access program at the
    ID Week 2018 Conference in October 2018. Thirteen patients with
    serious and life-threatening S. aureus infections were treated
    with AB-SA01 at the Westmead Hospital in Sydney. 83% (10 out of 12)
    patients in the modified intent-to-treat (mITT) population achieved
    treatment success at the end of therapy as reported by treating
    physicians. Bacteriophage treatment was well tolerated, with no
    adverse events attributable to the therapy.
  • Completed an underwritten public offering in October 2018 that raised
    gross proceeds of $6.8 million, before deducting underwriting
    discounts and commissions and other offering expenses. AmpliPhi
    anticipates using the net proceeds from the offering for general
    corporate purposes, including manufacturing, research and development
    and general and administrative expenses.

Third Quarter and Nine Months Ended September 30, 2018 Financial
Results

  • Research and development (R&D) expenses for the third quarter of 2018
    were $0.4 million compared to an $0.8 million benefit for the third
    quarter of 2017. The change was primarily attributable to a $1.2
    million tax incentive payment received in July 2018 from the
    Australian tax authority, compared to a $2.0 million tax incentive
    payment from the Australian tax authority received in the same quarter
    of 2017. Excluding any benefit from tax incentive payments, R&D
    expense was $1.6 million in the third quarter versus $1.2 million in
    the prior year period. The increase of $0.4 million was primarily
    attributable to a $0.3 million increase in clinical costs and a $0.1
    million increase in payroll-related costs.
  • R&D expenses for the nine months ended September 30, 2018, net of
    incentive tax payments, were $3.5 million, up from $1.8 million for
    the nine months ended September 30, 2017. Excluding any benefit from
    tax incentive payments, R&D expense for the nine months ended
    September 30, 2018 and 2017 were $4.7 million and $3.8 million,
    respectively. The increase of $0.9 million was primarily related to a
    $0.7 million increase in clinical costs, a $0.1 million increase in
    professional and consulting fees, and a $0.1 million increase in
    payroll-related costs.
  • General and administrative (G&A) expenses were $1.3 million for the
    third quarter of 2018 compared to $1.6 million for the third quarter
    of 2017. The decrease was primarily due to lower legal and
    professional fees, as well as a $0.1 million decrease in certain
    non-cash charges.
  • G&A expenses for the nine months ended September 30, 2018 decreased by
    $2.1 million to $4.2 million from $6.3 million for the nine months
    ended September 30, 2017. The decrease was primarily attributable to a
    decrease in payroll-related costs and professional fees and the
    non-recurrence of a non-cash fair value adjustment charge of $0.5
    million.
  • Net cash used in operating activities for the nine months ended
    September 30, 2018 was $7.0 million compared to $6.8 million for the
    nine months ended September 30, 2017.
  • Cash and cash equivalents as of September 30, 2018 totaled $4.5
    million, which excludes the proceeds from the company's October 2018
    public offering.
  • As of November 5, 2018, there were approximately 32.3 million shares
    of common stock outstanding.

About AmpliPhi Biosciences

AmpliPhi Biosciences Corporation is a clinical-stage biotechnology
company focused on precisely targeted bacteriophage therapeutics for
antibiotic-resistant infections using its proprietary
bacteriophage-based technology. AmpliPhi's lead product candidates,
AB-SA01 and AB-PA01, target Staphylococcus aureus and Pseudomonas
aeruginosa,
including multidrug-resistant strains, which are
included on the WHO's 2017 Priority Pathogens List. Phage therapeutics
are uniquely positioned to address the threat of antibiotic-resistance
as they can be precisely targeted to kill select bacteria, have a
differentiated mechanism of action, can penetrate and disrupt biofilms
(a common bacterial defense mechanism against antibiotics), are
potentially synergistic with antibiotics and have been shown to restore
antibiotic sensitivity to drug-resistant bacteria. For more information
visit www.ampliphibio.com.

Forward-Looking Statements

Statements in this press release that are not statements of historical
fact are forward-looking statements within the meaning of the Private
Securities Litigation Reform Act of 1995. Such forward-looking
statements include, without limitation, statements regarding: AmpliPhi's
intention to initiate a randomized clinical trial of AB-SA01 for S.
aureus
bacteremia in 2019; the potential benefits of phage therapy;
and the potential use of bacteriophages to treat bacterial infections,
including infections that do not respond to antibiotics or are
associated with biofilms. Words such as "believe," "anticipate," "plan,"
"expect," "intend," "will," "may," "goal," "potential" and similar
expressions are intended to identify forward-looking statements, though
not all forward-looking statements necessarily contain these identifying
words. Among the factors that could cause actual results to differ
materially from those indicated in these forward-looking statements are
the risk that AmpliPhi may not be able to obtain sufficient capital to
initiate a randomized clinical trial of AB-SA01 for S. aureus
bacteremia in 2019, risks and uncertainties associated with
bacteriophage product candidate development, both generally and
specifically through expanded access regulations, AmpliPhi's financial
condition, and other risks and uncertainties described in AmpliPhi's
Annual Report on Form 10-K for the year ended December 31, 2017, as
filed with the Securities and Exchange Commission (SEC), and AmpliPhi's
subsequent filings with the SEC. You are cautioned not to place undue
reliance on these forward-looking statements, which speak only as of the
date of this press release. All forward-looking statements are qualified
in their entirety by this cautionary statement, and AmpliPhi undertakes
no obligation to revise or update any forward-looking statements to
reflect events or circumstances after the date of this press release.

AmpliPhi Biosciences Corporation
Condensed Consolidated Balance Sheets
   
September 30, 2018 December 31, 2017
(Unaudited)
Assets
Cash and cash equivalents $ 4,499,000 $ 5,132,000
Prepaids and other current assets   615,000   253,000
Total current assets 5,114,000 5,385,000
Property and equipment, net 591,000 816,000
Intangible assets, net   4,914,000   4,937,000
Total assets $ 10,619,000 $ 11,138,000
 
Liabilities and stockholders' equity
Total current liabilities $ 2,465,000 $ 1,968,000
Derivative liabilities 154,000 292,000
Deferred tax liability   1,147,000   1,147,000
Total liabilities 3,766,000 3,407,000
 
Stockholders' equity   6,853,000   7,731,000
Total liabilities and stockholders' equity $ 10,619,000 $ 11,138,000
 
AmpliPhi Biosciences Corporation
Condensed Consolidated Statements of Operations
       
Three Months Ended September 30, Nine Months Ended September 30,
  2018       2017     2018       2017  
(Unaudited) (Unaudited) (Unaudited) (Unaudited)
 
Revenue $ - $ 38,000 $ - $ 95,000
Operating expenses:
Research and development (benefit) 361,000 (829,000 ) 3,517,000 1,791,000
General and administrative 1,276,000 1,613,000 4,227,000 6,295,000
Impairment charges   -     -     -     5,800,000  
Total operating expenses   1,637,000     784,000     7,744,000     13,886,000  
Loss from operations   (1,637,000 )   (746,000 )   (7,744,000 )   (13,791,000 )
Other income (expense):
Change in fair value of derivative liabilities 31,000 (37,000 ) (46,000 ) 1,997,000
Other income, net   -     4,000     -     6,000  
Total other income (expense), net   31,000     (33,000 )   (46,000 )   2,003,000  
Loss before income taxes (1,606,000 ) (779,000 ) (7,790,000 ) (11,788,000 )
Income tax benefit   -     -     -     1,302,000  
Net loss $ (1,606,000 ) $ (779,000 ) $ (7,790,000 ) $ (10,486,000 )
Net loss per share, basic $ (0.10 ) $ (0.09 ) $ (0.51 ) $ (1.97 )
Weighted average shares outstanding, basic   16,468,308     8,874,813     15,418,146     5,326,139  
Net loss per share, diluted $ (0.10 ) $ (0.09 ) $ (0.51 ) $ (2.18 )
Weighted average shares outstanding, diluted   16,496,957     8,874,813     15,418,416     5,518,847  
 
AmpliPhi Biosciences Corporation
Condensed Consolidated Statement of Cash Flows
   
Nine Months Ended September 30,
  2018       2017  
(Unaudited) (Unaudited)
Operating activities:
Net loss $ (7,790,000 ) $ (10,486,000 )
Adjustments required to reconcile net loss to net cash used in
operating activities:
Change in fair value of derivative liabilities 46,000 (1,997,000 )
Stock-based compensation 366,000 568,000
Charge for common stock issuance - 519,000
Depreciation and amortization 291,000 278,000
Other non-cash adjustments, net - 22,000
Impairment charges - 5,800,000
Deferred taxes - (1,302,000 )
Changes in operating assets and liabilities, net   133,000     (225,000 )
Net cash used in operating activities   (6,954,000 )   (6,823,000 )
Investing activities:
Purchases of property and equipment   (41,000 )   (40,000 )
Net cash used in investing activities   (41,000 )   (40,000 )
Financing activities:
Proceeds from sale of common stock, net of offering costs 6,159,000 9,353,000
Other financing activities   203,000     (476,000 )
Net cash provided by financing activities   6,362,000     8,877,000  
Net increase (decrease) in cash and cash equivalents (633,000 ) 2,014,000
Cash and cash equivalents, beginning of period   5,132,000     5,711,000  
Cash and cash equivalents, end of period $ 4,499,000   $ 7,725,000  

View Comments and Join the Discussion!